Tag Archives: breakthrough therapies

FDA: From Risk Aversion to Approval Activism

By Ben Comer | Published: May 7, 2013

During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news. On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based [...]

Posted in Agency Insight, Biotech, FDA, Legal, Market Access, Orphan Drugs, People, R&D, Regulatory, Strategy, leadership | Also tagged access, CDER, Cole Werble, FDA, IMS, Rachel Sherman, Regulatory | 2 Comments

Patients on the Picket Line

By Ben Comer | Published: February 5, 2013

Good science can’t be rushed, even when the lives of patients hang in the balance. But regulatory science, and its relationship to a drug’s commercial success or failure, can inadvertently block access to individual patients in their hour of need.

Posted in Biotech, FDA, Legal, Market Access, Regulatory, Safety, healthcare | Also tagged Abigail Alliance, Breast cancer, Cancer, compassionate use, Expanded Access Programs, FDA, FDA safety and innovation act, HHS, Market Access, patient advocates, PDUFA V, policy | Leave a comment